Type 1 Diabetes TrialNet: Toronto Clinical Center

1 型糖尿病 TrialNet：多伦多临床中心

• 批准号: 9268747
• 负责人: DIANE K WHERRETT
• 金额: $ 43.74万
• 依托单位: HOSPITAL FOR SICK CHLDRN (TORONTO)
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-20 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9268747
• 关键词: Adult; Antibodies; Autoantibodies; Autoimmunity; Beta Cell; CD3 Antigens; CTLA4-Ig; Canada; Cell Survival; Clinical; Collaborations; Communities; Community Networks; Complications of Diabetes Mellitus; Consent Forms; Data; Data Collection; Development; Diabetes Mellitus; Diabetes prevention; Disease; Effectiveness; Eligibility Determination; Enrollment; Event; Fellowship; Glutamate Decarboxylase; Goals; Human; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Leadership; Link; Methods; Mission; Monitor; Oral; Participant; Pathogenesis; Pathway interactions; Phase; Population; Prevention; Process; Protocols documentation; Randomized; Recombinants; Recruitment Activity; Reporting; Research Personnel; Resource Development; Risk; Role; Site; Study Subject; Therapy trial; Time; Training; Travel; Visit; cost; diabetes risk; follow-up; glucose tolerance; impaired glucose tolerance; improved; innovation; insight; insulin secretion; meetings; member; novel therapeutics; prevent; public health relevance; retention rate; screening; success; tool

 DESCRIPTION (provided by applicant): Despite effective current therapies for Type 1 diabetes (T1D), significant risks of long term complications of diabetes exist. Multiple studies have demonstrated that autoimmunity associated with type 1 diabetes is found years before its clinical presentation and that T1D can be predicted. The goals of the Type 1 Diabetes TrialNet Study Group are to prevent loss of beta cells through study of the pathogenesis of T1D and trials of therapies to intervene in the process. To reach TrialNet's goal, successful Clinical Centers must maintain and develop highly effective recruitment approaches, encourage participation of subjects in follow up and prevention studies and carry out studies in a highly efficient and accurate manner. In addition, they must contribute to the overall mission by engagement in TrialNet activities and committees and adding clinical and/or scientific expertise. The aims of this application reflect our center's approach to meeting TrialNet's mission: • To describe the progress and function of the Toronto Clinical Center as an innovative and effective TrialNet site that has developed an extensive regional and national network with broad links in the diabetes community. As a result, our site ranks 5th of 18 Clinical Centers in the number of subjects enrolled in screening and monitoring phases of the Pathway to Prevention study with a very high retention rate of over 90%. Careful analysis of the effectiveness of recruitment approaches through the use of reports from TrialNet's Coordinating Center and data collected by our site has allowed us to optimize efforts yielding an increase in the number of subjects screened for the Pathway to Prevention Study over the past 3 years. • To illustrate leadership and collaborative roles in TrialNet efforts such as Dr. Wherrett's leadership of the Study of Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects Study, management of all Canadian regulatory requirements for our site and the Canadian Affiliate Network, and our coordinators' roles in developing materials to support recruitment. • To highlight approaches used to assist Affiliate Sites with training and specialized support such as screening event identification and development. Methods to enhance recruitment and cost efficiency through new links, optimize efficiency of IRB review through the development of shared tools for review and consent documents, monitor the success of recruitment efforts and study conduct are detailed. A proposal for a fellowship to support new clinical researchers in type 1 diabetes is described.

 描述（由申请人提供）：尽管目前1型糖尿病（T1 D）治疗有效，但仍存在糖尿病长期并发症的重大风险。多项研究表明，与1型糖尿病相关的自身免疫性在其临床表现前几年就已发现，并且可以预测T1 D。1型糖尿病TrialNet研究小组的目标是通过研究T1 D的发病机制和干预该过程的治疗试验来防止β细胞的损失。为了实现TrialNet的目标，成功的临床中心必须保持和发展高效的招募方法，鼓励受试者参与随访和预防研究，并以高效和准确的方式开展研究。此外，他们必须通过参与TrialNet活动和委员会以及增加临床和/或科学专业知识，为总体使命做出贡献。本申请的目的反映了我们中心满足TrialNet使命的方法：·描述多伦多临床中心作为一个创新和有效的TrialNet网站的进展和功能，该网站已开发出一个广泛的区域和国家网络，与糖尿病社区有广泛的联系。因此，我们的研究中心在预防途径研究的筛选和监测阶段入组的受试者数量方面在18个临床中心中排名第5，留存率非常高，超过90%。通过使用TrialNet协调中心的报告和我们网站收集的数据对招募方法的有效性进行仔细分析，使我们能够优化工作，从而增加了过去3年中预防途径研究筛选的受试者数量。·说明在TrialNet工作中的领导和协作作用，例如Wherrett博士领导的重组人谷氨酸脱羧酶对新发受试者中1型糖尿病进展的影响研究，对我们网站和加拿大附属网络的所有加拿大监管要求的管理，以及我们的协调员在开发材料以支持招聘方面的作用。·强调用于通过培训和专业支持（如筛选事件识别和开发）来协助关联网站的方法。详细介绍了通过新链接提高招募和成本效率的方法，通过开发审查和同意文件的共享工具优化IRB审查效率的方法，以及监测招募工作和研究实施的成功方法。一个奖学金的建议，以支持新的临床研究人员在1型糖尿病的描述。